FDA Approves Filkri, Accord BioPharma's Biosimilar to Neupogen

The U.S. Food and Drug Administration has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), from Accord BioPharma, Inc. The approval was announced on February 17, 2026.

Filkri, a leukocyte growth factor, is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. The biosimilar is also indicated to reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia.

Additional approved indications include reducing the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation. Filkri is also indicated to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. The biosimilar is further indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).

The approval was based on two randomized studies in healthy adults that assessed the pharmacokinetics, safety, and immunogenicity of filgrastim-laha versus Neupogen. Findings showed the biosimilar and reference product were highly similar; no clinically meaningful differences were observed between the agents. These studies demonstrated biosimilarity in pharmacodynamic and pharmacokinetic parameters between Filkri and Neupogen and showed overall safety and immunogenicity similar to Neupogen.

Filkri is supplied in single-dose prefilled syringes containing 300mcg or 480mcg of filgrastim-laha in a preservative-free solution. The 300 mcg presentation is supplied as 300 mcg/0.5 mL and the 480 mcg presentation as 480 mcg/0.8 mL.

The approval marks the sixth product in Accord BioPharma's growing portfolio of FDA-approved biosimilars, following the company's acquisition last year of Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim), as well as the seventh approved product in the overall portfolio. With the addition of Filkri, Accord BioPharma now offers physicians in the U.S. a comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio with both long-acting (Udenyca) and short-acting (Filkri) biosimilar options.

Accord has applied for and expects to receive a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services, which will standardize and facilitate the billing and reimbursement process across hospital outpatient, ambulatory surgery center, and physician office settings of care.

Filkri belongs to the G-CSF class and is a growth factor manufactured by recombinant DNA technology. Filkri works by regulating the production of neutrophils within the bone marrow. Neutropenia is a common and potentially serious complication of cancer treatment and occurs when white blood cells called neutrophils—which serve as a major line of defense against bacterial and fungal infections—fall below normal levels. This reduction increases a person's risk of developing an infection. By accelerating neutrophil recovery, G-CSF can help reduce the duration of neutropenia.

Filkri is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products.

Warnings and precautions associated with Filkri include fatal splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions including anaphylaxis, fatal sickle cell crises, glomerulonephritis, myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), thrombocytopenia, and aortitis. Patients who report left upper abdominal or shoulder pain should be evaluated for an enlarged spleen or splenic rupture. Filkri should be discontinued in patients with ARDS and permanently discontinued in patients with serious allergic reactions. Patients with breast and lung cancer using Filkri in conjunction with chemotherapy and/or radiotherapy should be monitored for signs and symptoms of MDS/AML. Platelet counts should be monitored, and Filkri should be discontinued if aortitis is suspected.

Most common adverse reactions in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea. In patients with AML (≥ 2% difference in incidence), the most common adverse reactions are pain, epistaxis and rash. In patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (≥ 5% difference in incidence), the most common adverse reaction is rash. In patients with severe chronic neutropenia (≥ 5% difference in incidence), the most common adverse reactions are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

Filkri is the fifth FDA-approved biosimilar to Neupogen, after the approvals of Nypozi (filgrastim-txid) in 2024, Releuko (filgrastim-ayow) in 2022, Nivestym (filgrastim-aafi) in 2018, and Zarxio (filgrastim-sndz) in 2015.

Accord BioPharma is the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies. The company is strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market and has a strategic goal to launch 20 biosimilar products by 2030.